Bone positioning and preparing guide systems and methods

ABSTRACT

Methods for temporarily fixing an orientation of a bone or bones. Methods of correcting a bunion deformity. Bone positioning devices. Methods of using a bone positioning device. Bone preparation guides. Methods of using a bone preparation guide.

RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/452,236, filed Mar. 7, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/981,335, filed Dec. 28, 2015, which claims thebenefit of U.S. Provisional Application Ser. No. 62/205,338, filed Aug.14, 2015. The entire contents of these applications are herebyincorporated by reference.

TECHNICAL FIELD

This disclosure relates generally to devices and methods for positioningand/or preparing bones.

BACKGROUND

Bones, such as the bones of a foot, may be anatomically misaligned. Incertain circumstances, surgical intervention is required to correctlyalign the bones to reduce patient discomfort and improve patient qualityof life.

SUMMARY

Embodiments of the present invention include methods for temporarilyfixing an orientation of a bone or bones. In general, the method ofpositioning a bone includes the steps of moving a bone from ananatomically misaligned position to an anatomically aligned positionwith respect to another bone and preparing an end of the bone and afacing end of another bone. In some embodiments, at least one bone endis prepared after the bone is moved into the aligned position. In someembodiments, the bone is anatomically aligned in more than one planesuch that the bone both translates and rotates in response to a movingforce.

One embodiment includes a method of correcting a bunion deformity. Themethod has the steps of moving a first metatarsal from an anatomicallymisaligned position with respect to a second metatarsal to ananatomically aligned position with respect to the second metatarsal byapplying a force to the first metatarsal, the force moving the firstmetatarsal to correct an alignment in more than one plane. The methodcan also include preparing an end of the first metatarsal and preparingan opposing end of a medial cuneiform for fusion. Embodiments of theinvention also include a bone positioning device and a bone preparationguide, and methods of using such guides.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings are illustrative of particular embodiments of thepresent invention and, therefore, in no way limit the scope of theinvention. The drawings are not necessarily to scale (unless otherwisestated) and are intended for use in conjunction with the explanations inthe following detailed description. Embodiments of the invention willhereinafter be described with respect to the appended drawings, whereinlike numerals denote like elements.

FIG. 1 is a side perspective view of a bone positioning guide inaccordance with an embodiment of the invention.

FIG. 2 is a side perspective view of a bone engagement member of a bonepositioning guide in accordance with an embodiment of the invention.

FIG. 3A is a side perspective view of a tip of a bone positioning guidein accordance with an embodiment of the invention.

FIG. 3B is a side view of a bone positioning guide with a straight tipin accordance with an embodiment of the invention.

FIG. 3C is a side view of a bone positioning guide with a nonlinear tipin accordance with an embodiment of the invention.

FIG. 4 is an end view of an actuator of a bone positioning guide inaccordance with an embodiment of the invention.

FIG. 5 is a top plan view of a bone preparing guide in accordance withan embodiment of the invention.

FIG. 6A is a perspective view of a bone preparing guide, a spacer, and atissue removing instrument location check member in accordance with anembodiment of the invention.

FIG. 6B is a perspective view of another embodiment of a tissue removinginstrument check location member engaged with a bone preparing guide.

FIG. 7 is a perspective view of a bone preparing guide engaged with aspacer in accordance with an embodiment of the invention.

FIG. 8 is a perspective view of a bone preparing guide engaged with atissue removal instrument location check member in accordance with anembodiment of the invention.

FIG. 9A is a front view of a bone positioning guide on a deformed footin accordance with an embodiment of the invention.

FIG. 9B is a front view of a bone positioning guide on a foot with acorrected alignment in accordance with an embodiment of the invention.

FIG. 10A is a top view of a bone positioning guide on a deformed foot inaccordance with an embodiment of the invention.

FIG. 10B is a top view of a bone positioning guide on a foot with acorrected alignment in accordance with an embodiment of the invention.

FIGS. 11A-C depict a sequence of a bone positioning operation using abone positioning guide on a foot at first, second, and third positionsin accordance with an embodiment of the invention.

FIG. 12A is a front view of a foot with a normal first metatarsalposition.

FIG. 12B is a front view of a foot with an isolated first metatarsalrotation bunion deformity.

FIG. 13A is a top view of a foot with a normal first metatarsalposition.

FIG. 13B is a top view of a foot with an isolated first metatarsaltransverse plane bunion deformity.

FIG. 14A is a side view of a foot with a normal first metatarsalposition.

FIG. 14B is a side view of a foot with an isolated first metatarsalsagittal plane bunion deformity.

FIG. 15A is a perspective view and an enlarged view of a foot.

FIG. 15B is a perspective view of a first metatarsal.

FIG. 16 is a side perspective view of a foot depicting a bonepreparation instrument inserted into a joint.

FIG. 17 is a perspective view of a foot depicting a bone positioningguide on the foot prior to an alignment of a first metatarsal.

FIG. 18 is a perspective view of a foot depicting a bone positioningguide on the foot after an alignment of a first metatarsal.

FIG. 19 is a perspective view of a foot depicting a bone positioningguide on the foot after an alignment of a first metatarsal and aninsertion of a spacer into a joint space.

FIG. 20 is a perspective view of a foot depicting a bone positioningguide on the foot after an alignment of a first metatarsal and apositioning of a bone preparation guide.

FIG. 21A is a perspective view of a foot depicting a bone positioningguide on the foot after an alignment of a first metatarsal and apositioning of a bone preparation guide with pins.

FIG. 21B is another perspective view of a foot depicting a bonepositioning guide on the foot after an alignment of a first metatarsaland a positioning of a bone preparation guide with pins.

FIG. 22 is a perspective view of a foot depicting a bone preparationinstrument preparing a bone of the foot guided by a guide surface of abone preparation guide.

FIG. 23 is a perspective view of a foot depicting a bone positioningguide on the foot and a removal of a bone preparation guide.

FIG. 24 is a perspective view of a foot depicting a bone positioningguide on the foot and pins.

FIG. 25 is a perspective view of a foot depicting a bone positioningguide on the foot and a compression pin.

FIG. 26A is a side perspective view of a foot depicting bone platesacross a joint between first and second bones and a compression pin inaccordance with an embodiment of the invention.

FIG. 26B is a side perspective view of a foot depicting bone platesacross a joint between first and second bones and a compression pin inaccordance with an embodiment of the invention.

FIG. 27 is a side perspective view of a foot depicting bone platesacross a joint between first and second bones in accordance with anembodiment of the invention.

FIG. 28A and FIG. 28B depict examples of anatomically misalignedmetatarsals and metatarsals that have been anatomically aligned usingmethods and/or instruments in accordance with the invention.

FIG. 29A and FIG. 29B depict examples of anatomically misalignedmetatarsals and metatarsals that have been anatomically aligned usingmethods and/or instruments in accordance with the invention.

FIG. 30A illustrates a portion of a foot having a bunion caused by amisaligned first metatarsal relative to a second metatarsal.

FIG. 30B shows an example base compression that can be caused after thefoot of FIG. 30A is anatomically aligned.

FIG. 31 illustrates an example bone positioning operation in which afulcrum is positioned at an intersection between a first bone and asecond bone.

FIG. 32 is a perspective view of one example fulcrum.

FIG. 33 illustrates an example system of different sized fulcrums.

FIG. 34 is a perspective view of another bone positioning guideaccording to an embodiment of the invention.

FIG. 35 illustrates an example configuration of a joint spacer that canallow a bone preparation guide to rotate around the spacer.

FIG. 36A is a perspective view of an example configuration of a bonepositioning guide having an opening with circular cross-sectional shape.

FIG. 36B is a perspective view of the example bone positioning guide ofFIG. 36A shown with the joint spacer from FIG. 35 inserted into theguide.

DETAILED DESCRIPTION

The following detailed description is exemplary in nature and is notintended to limit the scope, applicability, or configuration of theinvention in any way. Rather, the following description providespractical illustrations for implementing exemplary embodiments of thepresent invention. Examples of constructions, materials, and dimensionsare provided for selected elements, and all other elements employ thatwhich is known to those of ordinary skill in the field of the invention.Those skilled in the art will recognize that many of the noted exampleshave a variety of suitable alternatives.

Embodiments of the invention include a bone positioning guide and methodof positioning bones in a medical procedure. In an exemplaryapplication, embodiments of the bone positioning guide can be usefulduring a surgical procedure, such as a bone alignment, osteotomy, fusionprocedure, and/or other procedures where one or more bones are to beprepared (e.g., cartilage or bone removal and/or cut). Such a procedurecan be performed, for example, on bones (e.g., adjacent bones separatedby a joint or different portions of a single bone) in the foot or hand,where bones are relatively smaller compared to bones in other parts ofthe human anatomy. In one example, a procedure utilizing an embodimentof the bone positioning guide can be performed to correct an alignmentbetween a metatarsal (e.g., a first metatarsal) and a second metatarsaland/or a cuneiform (e.g., a medial, or first, cuneiform), such as in abunion correction surgery. An example of such a procedure is a Lapidusprocedure (also known as a first tarsal-metatarsal fusion). In anotherexample, the procedure can be performed by modifying an alignment of ametatarsal (e.g., a first metatarsal). An example of such a procedure isa basilar metatarsal osteotomy procedure.

FIG. 1 shows a side perspective view of a bone positioning guide 10 inaccordance with an embodiment of the invention. The bone positioningguide 10 can be useful for positioning a bone (e.g., orientating and/ortranslating) during a medical procedure. In some embodiments, the bonepositioning guide includes a bone engagement member, a tip, a mechanismto urge the bone engagement member and the tip towards each other (e.g.moving the bone engagement member towards the tip, moving the tiptowards the bone engagement member, or moving both simultaneously), andan actuator to actuate the mechanism. When the mechanism is actuated itcauses a first bone engaged with the bone engagement member to move tocorrect an alignment in more than one plane with respect to a secondbone in contact with the tip. In some embodiments, the correction inmore than one plane includes a correction about an axis in a frontalplane.

In the embodiment of FIG. 1, bone positioning guide 10 includes a mainbody member 20 and a shaft 30, and the bone engagement member 40 isconnected to the shaft and the tip 50 is connected to the main bodymember. In general, the main body member 20 can be sized and shaped toclear anatomy or other instrumentation (e.g., pins and guides) whilepositioned on a patient. In the embodiment of FIG. 1, the main bodymember 20 includes a generally C-shaped configuration with a first end60 and a second end 70. In some embodiments, the main body is sized andconfigured to engage bones of a human foot. In addition, although bonepositioning guide 10 is illustrated as being formed of two components,main body member 20 and shaft 30, the guide can be fabricated from morecomponents (e.g., 3, 4, or more) that are joined together to form theguide.

A shaft 30 can be movably connected to the main body member 20 proximateits first end 60. In some embodiments, the shaft 30 includes threads 80that engage with the main body member 20 such that rotation of the shafttranslates the shaft with respect to the main body member. In otherembodiments, the shaft can slide within the main body member and can besecured thereto at a desired location with a set screw. In yet otherembodiments, the shaft can be moved with respect to the main body by aratchet mechanism. In the embodiment shown, the shaft moves along anaxis that intersects the tip 50. In other embodiments, such as thatdescribed with respect to FIG. 34, the shaft 30 and/or bone engagementmember 40 is offset from tip 50.

As shown in FIG. 2, embodiments of the bone positioning device can havea bone engagement member 40. In some embodiments, the bone engagementmember includes a surface 90 configured to contact a bone, such as ametatarsal or a cuneiform. In the embodiment shown, the surface 90 isconcave. Such a surface is adapted to promote surface contact with agenerally cylindrical bone, such as a metatarsal. Other embodiments ofsurface shapes include planar surfaces and V-shaped surfaces. When usinga concave or V-shaped bone engagement member 40, the sidewalls of theconcavity or V-shaped groove may be symmetrical or asymmetrical. In asymmetrical configuration, the bottom of the concavity or groove can becentered between upwardly extending sidewalls configured to receive abone. Each sidewall can extend upwardly to the same height and/or at thesame slope. In the asymmetrical configuration, one sidewall can have adifferent configuration than the opposing sidewall. For example, one ofthe sidewalls may extend upwardly from the bottom of the concavity orgroove to a lower height than the opposing sidewall. As another example,one sidewall may extend upwardly at a different angle than the opposingsidewall. The asymmetrical configuration can be useful for applying aforce that is biased laterally instead of only being linear toward tip50.

In some embodiments, bone engagement member 40 includes a pin or aclamp. Independent of whether bone engagement member 40 includes suchpin or clamp, the bone engagement member can engage an anatomicalfeature of a bone, such as a ridge (e.g., a medial ridge of a firstmetatarsal). In such embodiments, the engagement generally prohibitsrotational movement of the bone with respect to the bone engagementmember. In other embodiments, bone may be allowed to rotate with respectto the bone engagement member.

In the embodiment shown, the bone engagement member 40 is provided on anend of the shaft 30. In the embodiment of the shaft shown having threads80, the bone engagement member 40 can be rotatably coupled to the shaft30. In such embodiments, as the shaft is rotated relative to the mainbody member the bone engagement member 40 may or may not rotate withrespect to the main body member even as it translates with respect tothe main body member along with the shaft 30 and rotates with respect tothe shaft. The bone engagement member may oscillate about the shaft 30,but generally does not rotate with respect to bone after contact withthe bone.

FIGS. 3A-C depict a tip 50 of bone positioning guide 10, which can be ata second end 70 of the main body member opposite the first end. The tip50 can be useful for contacting a bone, generally a bone distinct from abone contacting the bone engagement member. For example, if the boneengagement member is in contact with a first metatarsal, the tip can bein contact with a metatarsal other than the first metatarsal (e.g., thesecond, third, fourth, or fifth metatarsal). In some embodiments, thetip is tapered to facilitate percutaneous insertion and contact withbone. The tip can also include a textured surface 100, such as serrated,roughened, cross-hatched, knurled, etc., to reduce slippage between thetip and bone. In the embodiment shown, the tip further includes a stop110 to limit a depth of insertion. The shape of the tip can beconfigured to stably contact bone. For example, FIG. 3B shows a sideview of the bone positioning guide with a generally straight tip 50,while FIG. 3C shows a side view of the bone positioning guide with anonlinear tip 50 (e.g., a tip that is angled or curved). In someembodiments, the tip is configured to restrict translational movementbetween it and a bone, but to allow rotational movement between it andthe bone.

As shown in FIG. 4, bone positioning guide 10 can also include anactuator (e.g., a knob or a handle) 120 to actuate the mechanism, inthis embodiment associated with the shaft. In the embodiment shown, theactuator can be useful for allowing a user to rotate the shaft withrespect to the main body member 20. Also as shown in FIG. 4, theactuator, shaft, and bone engagement member may include a cannulation130 to allow the placement of a fixation wire (e.g., K-wire) throughthese components and into contact with or through a bone engaged withthe bone engagement member. For example, the fixation wire can be placedinto the bone engaged with bone engagement member 40 to fix the positionof the bone engagement member with respect to the bone. In anotherexample, the fixation wire can be placed through the bone in contactwith the bone engagement member and into an adjacent bone to maintain abone position of the bone in contact with the bone engagement member andthe adjacent bone.

In other embodiments, the mechanism to urge the bone engagement memberand the tip towards each other can include a tenaculum or tongstructure. In such embodiments, the guide can include a first shaftpivotably connected to a second shaft. A first end of each shaft caninclude an actuator, such as a handle. A second end of the first shaftcan include a bone engagement member, as described above. And a secondend of the second shaft can include a tip, as described above. In use,the actuator can be actuated (e.g., squeezed together) to move the boneengagement member and the tip closer together to position bone. Otherembodiments of this type may include another set of shafts and anotherpivoting connection such that the bone engagement member and tiptranslate towards each other when the actuator is actuated.

In other embodiments, the mechanism to urge the bone engagement memberand the tip towards each other can include a rack and pinion structure.In such embodiments, the rack can include a tip, as described above. Andthe pinion can include a bone engagement member, as described above, andan actuator (e.g., a knob). In use, the actuator can be actuated (e.g.,turned about an axis generally perpendicular to a direction of travel)to move the bone engagement member and the tip closer together toposition bone.

Embodiments of the bone positioning guide may include any suitablematerials. In certain embodiments, the bone positioning guide isfabricated from a radiolucent material such that it is relativelypenetrable by X-rays and other forms of radiation, such asthermoplastics and carbon-fiber materials. Such materials are useful fornot obstructing visualization of bones using an imaging device when thebone positioning guide is positioned on bones.

Embodiments of the bone positioning guide can be useful in operation fortemporarily positioning a bone or bones during a medical procedure. Bonepositioning can be useful, for instance, to correct an anatomicalmisalignment of bones and temporarily maintain an anatomically alignedposition, such as in a bone alignment and/or fusion procedure. In someembodiments, the bone positioning guide is capable of reducing an anglebetween the first metatarsal and the second metatarsal from over 10degrees (e.g., up to about 35 degrees) to about 10 degrees or less(e.g., to about 1-5 degrees), including to negative angles of about −5degrees. In some embodiments, the bone positioning guide is also capableof rotating the first metatarsal about its long axis with respect to themedial cuneiform from a rotational angle of over 4 degrees to arotational angle of less than 4 degrees (e.g., to about 0 to 2 degrees).

In some embodiments, a bone preparation guide may be provided tofacilitate the preparation of a bone. The bone preparation guide can beprovided with a bone positioning guide, or either device can be providedor used independently. An example of a bone preparation guide 150 isshown in FIG. 5. In some embodiments, the bone preparation guide 150includes a body 154 defining a first guide surface 160 to define a firstpreparing plane and a second guide surface 164 to define a secondpreparing plane. A tissue removing instrument (e.g., a saw, rotary bur,osteotome, etc., not shown) can be aligned with the surfaces to removetissue (e.g., remove cartilage or bone and/or make cuts to bone). Thefirst and second guide surfaces 160, 164 can be spaced from each otherby a distance, (e.g., between about 2 millimeters and about 10millimeters, such as between about 4 and about 7 millimeters). In theembodiment shown, the first and second guide surfaces are parallel, suchthat cuts to adjacent bones using the guide surfaces will be generallyparallel.

In some embodiments, as shown in FIG. 5, a first facing surface 166 ispositioned adjacent the first guide surface 160 and/or a second facingsurface 168 is positioned adjacent the second guide surface 164. In suchembodiments, the distance between the first guide surface and the firstfacing surface defines a first guide slot, and the distance between thesecond guide surface and the second facing surface defines a secondguide slot. Each slot can be sized to receive a tissue removinginstrument to prepare the bone ends. The first and second slots may beparallel or skewed. In the illustrated embodiment, the facing surfaceseach contain a gap, such that the surface is not a single, continuoussurface. In other embodiments, the facing surfaces can be a single,continuous surface lacking any such gap.

An opening 170 can be defined by the body 154 between the first andsecond guide surfaces. The opening can be an area between the guidesurfaces useful for allowing a practitioner to have a visual path tobones during bone preparation and/or to receive instruments. In theembodiment shown, the opening extends across the body and a distancefrom a surface 172 opposite of the first facing surface 166 to a surface174 opposite of the second facing surface 168.

The embodiment shown also includes a first end 176 extending from thebody 154 in a first direction and a second end 178 extending from thebody in a second direction. The second direction can be different thanthe first direction (e.g., an opposite direction). As shown, each of thefirst end and the second end can include at least one fixation aperture180 configured to receive a fixation pin (not shown in FIG. 5) to securethe guide to a bone. As shown, such apertures may extend through the endat a vertical or skewed angle relative to a top surface of the guide.

The bone preparation guide 150 can also include a first adjustablestabilization member 182 engaged with the first end 176. In someembodiments, the bone preparation guide can include a second adjustablestabilization member 184 engaged with the second end 178. Each of themembers can be threaded and engage a threaded aperture defined by theends. The elevation of each end can be adjusted with respect to a boneby adjusting the stabilization member. In some embodiments, as shown,the stabilization members are cannulated such that they can receive afixation pin.

As shown in FIGS. 6A and 7, the bone preparation guide can also includea spacer 188 extending downward from the body 154 and configured to beplaced into a joint. In some embodiments, the spacer 188 is selectivelyengageable with the body. The spacer can have a first portion 190configured to extend into a joint space and a second portion 192engageable with the body 154. In the embodiment shown, the spacer can bereceived within opening 170, such that the spacer extends from the bodyin between the first and second guide surfaces. Such a spacer can beuseful for positioning the body at a desired position with respect to ajoint and for properly positioning the guide with respect to bones to becut in more than one plane (e.g., three planes selected from more thanone of a frontal plane, a transverse plane, and a sagittal plane). Thedistance between the spacer and the first guide surface can define alength of tissue removal (e.g., bone or cartilage to be cut) from afirst bone, and the distance between the spacer and the second guidesurface can define a length of tissue removal (e.g., bone or cartilageto be cut) from a second bone.

As shown in FIGS. 6A/B and 8, the bone preparation guide can alsoinclude a tissue removal location check member 194 engageable with thebody 154 and configured to extend to a first bone and a second bone. Thetissue removal location check member can have a first portion 196configured to extend into contact with first and second bones and asecond portion 198 engageable with the body. In the embodiments shown inFIGS. 6A and 8, the tissue removal location check member extends fromthe body at both the first and second guiding surfaces. In otherembodiments, such as the embodiment shown in FIG. 6B, separate tissueremoval location check members are provided for independent insertioninto respective slots of the guide. Accordingly, embodiments of tissueremoval location check members are useful for allowing a practitioner tosee where a tissue removing instrument guided by the surfaces willcontact the bone to be prepared.

Embodiments of the bone preparation guide can be useful in operation forguiding a preparation of a bone or bones at a targeted anatomy. Bonepreparation can be useful, for instance, to facilitate contact betweenleading edges of adjacent bones, separated by a joint, or differentportions of a single bone, separated by a fracture, such as in a bonealignment and/or fusion procedure.

Embodiments of the present invention also include methods fortemporarily fixing an orientation of a bone or bones, for example, priorto or in conjunction with permanently fixing the orientation of the boneor bones. In general, the method of positioning a bone includes thesteps of moving a bone from an anatomically misaligned position to ananatomically aligned position with respect to another bone and preparingan end of the moved bone and a facing end of another bone. In someembodiments, the end of at least one of the moved bone and the otherbone is prepared after moving the bone into the aligned position. Incertain embodiments, the bone is anatomically aligned in more than oneplane with respect to another bone by applying a force to one bone at asingle location, such that the bone both translates and rotates inresponse to the force. In certain embodiments, the moving step can beaccomplished with a bone positioning device and/or the preparing stepcan be accomplished with a bone preparation guide, as described herein.

FIGS. 9A-B depict fontal views of a bone positioning guide 10 on a foot200 having a first metatarsal 210, a medial cuneiform 220, a secondmetatarsal 292, and a third metatarsal 294. FIG. 9A depicts a foot 200with an uncorrected bunion deformity, while FIG. 9B depicts the foot 200with an alignment corrected by the bone positioning guide 10. Solid lineL1 represents the starting location of the bone positioning guide 10 anddotted line L2 represents the finishing location of the bone positioningguide. As shown, as the bone positioning guide 10 is actuated it rotateswith the first metatarsal 210 about an axis extending through thefrontal plane as it pushes the first metatarsal 210 laterally in thetransverse plane and plantarly in the sagittal plane. Accordingly, inthis example, the position of the first metatarsal 210 is corrected withrespect to the second metatarsal 292 generally in three planes byactuating a single bone positioning guide 10 to urge a bone engagementmember 40 toward a tip 50. FIG. 10A shows a top view of a foot 200 withan uncorrected bunion deformity, while FIG. 10B shows a top view of thefoot 200 with an alignment corrected by the bone positioning guide 10,emphasizing the rotational correction in the frontal plane and thelateral correction in the transverse plane.

FIGS. 11A-C show three sequential images of a bone positioning guide 10on a foot 200 positioning a first metatarsal 210 with respect to asecond metatarsal 292. FIG. 11A represents the beginning of theprocedure, FIG. 11B the middle, and FIG. 11C the end. The orientation ofthe pins 270 is useful for visualizing the amount of rotation of thefirst metatarsal 210 in each image. With respect to FIGS. 11A-C, it canbe seen the bone positioning guide 10 and the first metatarsal 210 arerotating in the frontal plane in response to actuation of bonepositioning guide 10. Further, the angle between the first metatarsal210 and second metatarsal 292 is reduced, as the space that can be seenbetween the first and second metatarsals in FIG. 11A is eliminated inFIG. 11C.

Each of the three potential planes of deformity will now be described inisolation. FIGS. 12A and 12B show frontal plane views of a foot 200. InFIG. 12A, the foot 200 is normal, while in FIG. 12B the foot is depictedwith an uncorrected bunion deformity showing an isolated axial rotationof the first metatarsal 210. Solid line L3 indicates the alignment ofthe first metatarsal 210 relative to ground, while dotted line L4 inFIG. 12B indicates the extent of axial rotation in the frontal plane.

FIGS. 13A and 13B show transverse plane views of a foot 200. In FIG.13A, the foot 200 is normal, while in FIG. 13B the foot is depicted withan uncorrected bunion deformity showing an isolated transverse planefirst metatarsal 210 deviation. Solid line L5 indicates the alignment ofthe second metatarsal 292 and solid line L6 indicates the properalignment of the first metatarsal 210 relative to the second metatarsal292. The angle between these two lines forms the intermetatarsal angle(IMA). Dotted line L7 in FIG. 13B indicates the extent of transversedeviation.

FIGS. 14A and 14B show sagittal plane views of a foot 200. In FIG. 14A,the foot 200 is normal, while in FIG. 14B the foot is depicted with anuncorrected bunion deformity showing an isolated sagittal deviation ofthe first metatarsal 210. Solid line L8 indicates the proper alignmentof the first metatarsal 210, while dotted line L9 in FIG. 14B indicatesthe extent of sagittal deviation.

A specific embodiment of a method in accordance with an embodiment ofthe invention includes the steps of engaging a bone engagement memberwith a first bone, placing a tip of the bone positioning guide inapposition to a second bone, the second bone being different from thefirst bone, and moving the bone engagement member with respect to thetip to change the position of the first bone with respect to the secondbone in more than one plane. In some embodiments, after alignment, atleast one of an end of the first bone and a facing end of a third boneare prepared (e.g., only the end of the first bone or both the end ofthe first bone and the end of the second bone), optionally using apreparation guide.

In some embodiments, the method includes the step of mobilizing a jointfor a corrective procedure. For example, after creating surgical accessto the joint and before moving the bones into an aligned position,tissue can be released to allow a bone, such as a metatarsal, to rotatefreely. In some embodiments, obstructing bone may be excised (e.g., adorsolateral flare of the metatarsal base, a plantar flare of themetatarsal base (sometimes referred to as a plantar condyle), part of anend of a metatarsal facing a cuneiform, or osteophyte) to furtherpromote free rotation by creating relatively flat surfaces with respectto a frontal plane. An example of a dorsolateral flare F on a firstmetatarsal 210 of a foot 200 is shown in FIG. 15A. An example of aplantar flare PF on a first metatarsal 210 is shown in FIG. 15B. FIG.15B also depicts a medial ridge MR, which, in some embodiments, can beengaged by the bone engaging member of a bone positioning guide.

Embodiments of methods in accordance with the invention can also includesteps performed after preparing the ends of the bones. For example, theends of the bones may be placed in apposition and optionally compressedtogether and the position of the bones can be fixed with one or morebone fixation devices (e.g., compressing bone screw, bone plate, bonestaple, external fixator, intramedullary implant or nail) prior to aclosing of the surgical access to the joint.

An exemplary method will now be described with respect to FIGS. 16-27depicting a foot 200 having a first metatarsal 210, a medial cuneiform220, and a second metatarsal 292. Note, unless otherwise indicated, thesteps described need not be carried out in the order described.

After customary surgical preparation and access, a bone preparationinstrument 296 can be inserted into the joint (e.g., firsttarsal-metatarsal joint) to release soft tissues and/or excise theplantar flare from the base of the first metatarsal 210, as shown inFIG. 16. Excising the plantar flare may involve cutting plantar flareoff the first metatarsal 210 so the face of the first metatarsal isgenerally planar. This step helps to mobilize the joint to facilitate adeformity correction. In some embodiments, the dorsal-lateral flare ofthe first metatarsal may also be excised to create space for thedeformity correction (e.g., with respect to rotation of the firstmetatarsal). In certain embodiments, a portion of the metatarsal basefacing the medial cuneiform can be removed during this mobilizing step.

An incision can be made and a tip 50 of a bone positioning guide 10 canbe inserted on the lateral side of a metatarsal other than the firstmetatarsal 210, such as the second metatarsal 292. As shown in FIG. 17,the tip can be positioned proximally at a base of the second metatarsal292 and a third metatarsal 294 interface. A surface of a bone engagementmember 40 can be placed on the proximal portion of the first metatarsal210. In some embodiments, the bone engagement member engages a medialridge of the first metatarsal 210. As shown, the body 20 of thepositioning guide can be generally perpendicular to the long axis of thesecond metatarsal 292.

As depicted in FIG. 18, the actuator 120 can be actuated to extend theshaft 30 to reduce the angle (transverse plane angle between the firstmetatarsal and the second metatarsal) and rotate the first metatarsalabout its axis (frontal plane axial rotation). The first metatarsal 210can be properly positioned with respect to the medial cuneiform 220 bymoving the bone engagement member 40 with respect to the tip 50. In someembodiments, such movement simultaneously pivots the first metatarsalwith respect to the cuneiform and rotates the first metatarsal about itslongitudinal axis into an anatomically correct position to correct atransverse plane deformity and a frontal plane deformity. In certainembodiments, body 20 rotates in a generally lateral direction duringthis step. In some embodiments, fixation pins (not shown in FIG. 18) canbe inserted into the bones prior to the positioning step (e.g., freehandor using apertures in the guide as a template), and can be used toimpart additional force (transverse, sagittal, and/or frontal planerotational) to the first metatarsal 210, if desired. The bonepositioning guide 10 can hold the desired position of the firstmetatarsal 210 with respect to the second metatarsal 292. After thedesired correction is achieved, a fixation wire 298 can be insertedthrough a cannulation in the shaft 30 and driven into the firstmetatarsal 210 and the second metatarsal 292 to hold the correctedposition.

As depicted in FIG. 19, a joint spacer 188 can be positioned within thejoint between the first metatarsal and the medial cuneiform.

As shown in FIG. 20, a bone preparation guide 150 can be placed over thejoint spacer 188 and engaged with the joint spacer to set a position andorientation of the bone preparation guide relative to the joint. Asshown, the bone preparation guide 150 can be positioned proximal to thebone positioning guide 10 in longitudinal alignment with the long axisof the first metatarsal 210 and the medial cuneiform 220, generally onthe dorsal or dorsal-medial surface. In other embodiments, the spacer188 is positioned after the guide 150 is provisionally placed on thebones. In yet other embodiments, bone preparation guide 150 and jointspacer 188 are placed simultaneously. In still other embodiments, bonepreparation guide 150 is placed on the bones without using joint spacer188 to aid with positioning.

As depicted in FIGS. 21A and 21B, one or more fixation pins 270 can beinserted into apertures of the bone preparation guide 150 to secure theguide to the first metatarsal 210 and the medial cuneiform 220. Asshown, some pins 270 can be inserted at an angle or in a convergingorientation to help prevent movement of the bone preparation guide 150during a tissue removing step. As shown, two of the pins 270, one on thefirst metatarsal and one on the medial cuneiform, are parallel to allowthe bone preparation guide 150 to be removed from the foot withoutremoving all the pins. After insertion of the pins 270, the spacer 188can optionally be removed in embodiments having a selectively engageablespacer (e.g., a joint spacer 188 that is physically removable from bonepreparation guide 150).

In some embodiments, the location of the intersection of the tissueremoving instrument and the bone to be prepared is confirmed before bonepreparation. In one embodiment, a tissue removing instrument locationcheck member can be engaged with the preparation guide to visuallyconfirm where a tissue removal instrument will contact the bone. Inanother embodiment, a tissue removal instrument is engaged with thepreparation guide to visually confirm where the instrument will contactthe bone. In either embodiment, such visual confirmation can include theuse of an imaging device, such as an X-ray. If the position of thepreparation guide is correct, additional fixation pins may be insertedthrough the apertures (e.g., angled apertures) to further fix theposition of the preparation guide with respect to the first metatarsaland the medial cuneiform. In some embodiments, the spacer is reattachedprior to further bone preparation steps.

In some embodiments, the end of the first metatarsal 210 facing themedial cuneiform 220 can be prepared with a tissue removing instrument296 guided by a guide surface of bone preparation guide 150 (e.g.,inserted through a slot defined by a first guide surface and a firstfacing surface). In some embodiments, the first metatarsal 210 endpreparation is done after the alignment of the bones, e.g., by actuatingbone positioning guide 10 before preparing the end of first metatarsal210. In other embodiments, the first metatarsal 210 end preparation isdone before the alignment of the bones, e.g., by preparing the end ofthe first metatarsal 210 before actuating bone positioning guide 10.

In addition, as shown in FIG. 22, the end of the medial cuneiform 220facing the first metatarsal 210 can be prepared with the tissue removinginstrument 296 guided by a guide surface of bone preparation guide 150(e.g., inserted through a slot defined by a second guide surface and asecond facing surface). In some embodiments, the medial cuneiform 220end preparation is done after the alignment of the bones. In yet otherembodiments, the medial cuneiform 220 end preparation is done before thealignment of the bones. In embodiments that include cutting bone orcartilage, the cuneiform cut and the metatarsal cut can be parallel,conforming cuts. In the specific embodiment shown in FIG. 22, a sawblade can be inserted through a first slot to cut a portion of themedial cuneiform and the saw blade can be inserted through a second slotto cut a portion of the first metatarsal (e.g., in some embodiments themedial cuneiform can be cut before the first metatarsal). Accordingly,in the embodiment shown, the cuts to both the first metatarsal and themedial cuneiform were preformed after the first metatarsal waspositioned.

Any angled/converging pins can be removed and the bone preparation guide150 can be lifted off the parallel pins 270, as shown in FIG. 23. Theparallel pins can be referred to as “reference pins” which can serve asa reference in later steps to ensure that the corrected alignment of thefirst metatarsal 210 has been maintained. The joint spacer can also beremoved before, after, or simultaneously with the bone preparationguide. In some embodiments, the bone positioning guide 10 is alsoremoved from the foot.

The tissue (e.g., bone or cartilage slices) from the first metatarsaland the medial cuneiform can be removed from the joint site and thejoint surfaces can be fenestrated, if desired. If the bone positioningguide was taken off the foot, it can be put back on, as shown in FIG.24, before the additional steps discussed below.

After preparation, the ends of the two bones can be placed in appositionand optionally compressed together by provisionally fixating the joint.For example, the two bones may be placed in apposition by placing thecut end of the first metatarsal 210 in abutment with the cut end of themedial cuneiform 220. In some examples, the cut end of the firstmetatarsal 210 is placed adjacent to, and optionally in contact with,the cut end of the medial cuneiform 220.

As shown in FIG. 25, a compression pin, such as a threaded olive pin 300can be inserted through the first metatarsal 210 and into the medialcuneiform 220 to provide compression and provisional fixation betweenthe first metatarsal and the medial cuneiform. Additional compressionpins can be inserted to provide additional stability. As shown, theparallel reference pins should be aligned during this step. In someembodiments, a practitioner checks for alignment of the parallelreference pins prior to insertion of the compression pin, and, if theyare not aligned, adjusts the position of the first metatarsal untildesired alignment is achieved.

Although they can be left in place, in some embodiments the parallelreference pins and bone positioning guide can be removed and a bonefixation device (e.g., two bone plates positioned in different planes,as shown) can be applied to stabilize the joint for fusion. FIG. 26Ashows a first bone plate 310 positioned on a dorsal-medial side of thefirst metatarsal and medial cuneiform and a second bone plate 320positioned on a medial-plantar side of the first metatarsal and themedial cuneiform. In other embodiments, such as the embodiment shown inFIG. 26B, the second bone plate 320 can be a helical bone platepositioned from a medial side of the cuneiform to a plantar side of thefirst metatarsal across the joint space. The plates can be applied withthe insertion of bone screws.

As shown in FIG. 27, the compression pin can be removed and the incisioncan be closed.

FIGS. 28 A/B and 29A/B include examples of anatomically misalignedmetatarsals and metatarsals that have been anatomically aligned usingmethods and/or instruments in accordance with the invention. FIG. 28Ashows a left foot pre-operation and post-operation, while FIG. 28B showsa right foot pre-operation and post-operation. As can be seen from acomparison of the pre-operative images to the post-operative images, thepatients' intermetatarsal angle (IMA) was significantly reduced. FIGS.29A and 29B show the correction of an axial rotation in a frontalrotational plane. FIG. 29 A shows a pre-operative image and apost-operative image of a right foot. Drawings of a metatarsal 210 arealso provided to illustrate the rotation. The rotation of the metatarsalcan be seen by the position of sesamoid bones 400, which are depicted ashaving been rotated under the first metatarsal 210 in the post-operativedrawing. FIG. 29B shows pre-operative views of a left foot 200 and aright foot 200. Again, by comparing the location of the sesamoid bones400 with respect to a reference location, such as ground, the plantersurface of the foot, and/or a cuneiform, it can be seen this patient'smetatarsal is rotated out of alignment.

Methods in accordance with embodiments of the invention can be usefulfor temporarily positioning a bone or bones. Bone positioning can beuseful, for instance, to correct an anatomical misalignment of bones andtemporarily maintain an anatomically aligned position, such as in a bonealignment and/or fusion procedure. In some embodiments, an “anatomicallyaligned position” means that an angle of a long axis of a firstmetatarsal relative to a long axis of a second metatarsal is about 10degrees or less in the transverse plane or sagittal plane. In certainembodiments, anatomical misalignment can be corrected in both thetransverse plane and the frontal plane. In the transverse plane, anormal intermetatarsal angle (“IMA”) between a first metatarsal and asecond metatarsal is less than about 9 degrees. An IMA of between about9 degrees and about 13 degrees is considered a mild misalignment of thefirst metatarsal and the second metatarsal. An IMA of greater than about16 degrees is considered a severe misalignment of the first metatarsaland the second metatarsal. In some embodiments, methods in accordancewith the invention are capable of anatomically aligning the bone(s) byreducing the IMA from over 10 degrees to about 10 degrees or less (e.g.,to an IMA of about 1-5 degrees), including to negative angles of about−5 degrees or until interference with the second metatarsal, bypositioning the first metatarsal at a different angle with respect tothe second metatarsal.

With respect to the frontal plane, a normal first metatarsal will bepositioned such that its crista prominence is generally perpendicular tothe ground and/or its sesamoid bones are generally parallel to theground and positioned under the metatarsal. This position can be definedas a metatarsal rotation of 0 degrees. In a misaligned first metatarsal,the metatarsal is axially rotated between about 4 degrees to about 30degrees or more. In some embodiments, methods in accordance with theinvention are capable of anatomically aligning the metatarsal byreducing the metatarsal rotation from about 4 degrees or more to lessthan 4 degrees (e.g., to about 0 to 2 degrees) by rotating themetatarsal with respect to the medial cuneiform.

While various embodiments of bone positioning and preparing guidesystems and methods have been described, is should be appreciated thatthe concepts of the disclosure can be altered in practice, e.g., basedon the needs of the clinician, the patient undergoing the bonerepositioning procedure, the specific anatomy being treated, and/or thetarget clinical outcome. As one example, the described systems andtechniques may be modified to utilize a fulcrum about which rotationand/or pivoting of one bone relative to another bone occurs via bonepositioning guide 10. The fulcrum can establish and/or maintain spacebetween adjacent bones being compressed between bone engagement member40 and tip 50 of bone positioning guide 10, preventing lateraltranslation or base shift of the bones during rotation and pivoting.

FIG. 30A illustrates a portion of a foot having a bunion caused by amisaligned first metatarsal 210 relative to second metatarsal 292. FIG.30B shows the foot of FIG. 30A after being anatomically aligned tocorrect the misalignment using bone positioning guide 10. As shown,first metatarsal 210 has been rotated counterclockwise in the frontalplane (from the perspective of a patient, clockwise from the perspectiveof a frontal observer) and also pivoted in the transverse plane (e.g.,such that the angle 350 between the first metatarsal 210 and secondmetatarsal 292 is reduced). Rotation and pivoting of first metatarsal210 can cause the base 352 of first metatarsal 210 to shift relative tomedial cuneiform 220. In general, it is desirable that the offset 354Abetween first metatarsal 210 and medial cuneiform 220 be reduced to zero(e.g., such that there is substantially no offset) after rotation andpivoting. As shown in the illustrated application of FIG. 30B, however,the base 352 of first metatarsal 210 abutting medial cuneiform 220 hasshifted toward second metatarsal 292. This results in a transverseoffset 354B of first metatarsal 210 toward second metatarsal 292,causing base compression between first metatarsal 210 and secondmetatarsal 292.

To help avoid the base shift and offset 354B observed in FIG. 30B, aclinician can insert a fulcrum in the notch between first metatarsal 210and second metatarsal 292 at the base of the metatarsals (e.g., adjacentrespective cuneiform) before actuating bone positioning guide 10. Thefulcrum can provide a point about which first metatarsal 210 can rotateand/or pivot while helping minimize or avoid base compression betweenthe first metatarsal and the second metatarsal. In addition, use of thefulcrum may cause first metatarsal 210 and medial cuneiform 220 to bebetter angled relative to the guide slots of bone preparation guide 150(once installed), providing a better cut angle through the guide slotsthen without use of the fulcrum. This can help reduce or eliminateunwanted spring-back, or return positioning, of first metatarsal 210after removing bone positioning guide 10.

FIG. 31 illustrates a bone positioning operation in which a fulcrum 356is positioned at an intersection between a first bone and a second bone,where the first bone is being realigned relative to the second bone. Inparticular, FIG. 31 illustrates fulcrum 356 being positioned betweenfirst metatarsal 210 and second metatarsal 292. Fulcrum 356 may bepositioned distally of bone preparation guide 150 between firstmetatarsal 210 and second metatarsal 292 as shown in FIG. 31 or, inother applications, proximally of the guide (e.g., at the ends of thefirst and second metatarsals abutting the medial and intermediatecuneiform bones, respectively).

When used, the clinician can insert fulcrum 356 between first metatarsal210 and second metatarsal 292 (or other adjacent bones, when notperforming a metatarsal realignment) at any time prior to actuating bonepositioning guide 10. In different embodiments, fulcrum 356 can beinserted between first metatarsal 210 and second metatarsal 292 beforeor after inserting joint spacer 188 and/or placing bone preparationguide 150 over the joint being operated upon. In one embodiment, theclinician prepares the joint being operated upon to release soft tissuesand/or excise the plantar flare from the base of the first metatarsal210, as discussed above. Either before or after installing bonepositioning guide 10 over adjacent bones, for example with boneengagement member 40 positioned in contact with the medial ridge of thefirst metatarsal 210 and tip 50 positioned in contact with secondmetatarsal 292, the clinician inserts fulcrum 356 at the joint betweenthe first metatarsal and the second metatarsal. The clinician cansubsequently actuate bone positioning guide 10 (e.g., rotate knob 120).In the case of a left foot as shown in FIG. 31, actuation of bonepositioning guide 10 causes the first metatarsal 210 to rotatecounterclockwise in the frontal plane (from the perspective of apatient) and also pivot in the transverse plane about the fulcrum. Inthe case of a right foot (not shown), actuation causes the firstmetatarsal to rotate clockwise in the frontal plane (from theperspective of a patient) and also pivot in the transverse plane aboutthe fulcrum. Thus, for both feet, actuation of bone positioning guide 10can supinate the first metatarsal in the frontal plane and pivot thefirst metatarsal in the transverse plane about fulcrum 356. While use offulcrum 356 can minimize or eliminate base compression between adjacentbones being operated upon, in other embodiments as discussed above, thedescribed systems and techniques can be implemented without using thefulcrum.

In instances in which fulcrum 356 is used, any suitable mechanicalinstrument can be used for the fulcrum. FIG. 32 is a perspective view ofone example instrument that can be used as fulcrum 356. In thisembodiment, fulcrum 356 has a generally rectangular shape and tapers inthickness along at least a portion of the length from the trailing end358 to the leading end 360. Fulcrum 356 may be sized sufficiently smallso that it does not interfere with placement of bone preparation guide150 on the joint being worked upon. In some embodiments, the clinicianis provided a system containing multiple different size fulcrums andallowed to choose the specific sized fulcrum desired for the specificprocedure being performed. FIG. 33 illustrates an example kit or systemof different sized fulcrums, labeled with exemplary “width x thickness”sizes, that may be provided to a clinician in such an embodiment. Insome examples, fulcrum 356 has a width ranging from 5 millimeters to 15millimeters (e.g., about 6 millimeters to about 10 millimeters) and athickness ranging 1 millimeter to 12 millimeters (e.g., about 2millimeters to about 3 millimeters), although fulcrums with differentdimensions can be used. While FIGS. 32 and 33 illustrate one examplestyle of fulcrum, other mechanical instruments providing a fulcrumfunctionality can be used without departing from the scope of thedisclosure. For instance, as alternative examples, a surgical pin orscrew driver head may be used as fulcrum 356.

As discussed above, bone positioning guide 10 can have a variety ofdifferent configurations, including a configuration in which boneengagement member 40 is laterally offset from tip 50. FIG. 34 is aperspective view of bone positioning guide 10 showing an examplearrangement in which bone engagement member 40 is laterally offset fromtip 50. In this embodiment, the first end 60 of main body member 20 islaterally offset from an axis 362 extending through shaft 30 and ageometric center of bone engagement member 40. In particular, in theillustrated configuration, tip 50 is offset laterally in the directionof the cuneiform relative to bone engagement member 40. As a result,when bone positioning guide 10 is actuated, e.g., by rotating knob 120,a moment can be created by the offset tip. This can cause the end of thefirst metatarsal 210 adjacent the proximal phalange to pivot toward thesecond metatarsal 292 and close angle 350, e.g., while the opposite endof the first metatarsal adjacent the medial cuneiform pivots away fromthe second metatarsal. This can also help avoid base compression betweenthe first and second metatarsals.

As discussed above with respect to FIGS. 19 and 20, a joint spacer 188can be positioned in a joint between a first metatarsal and a medialcuneiform before placing bone preparation guide 150 over the jointspacer. Bone preparation guide 150 can have an opening 170 (FIG. 5)sized to receive joint spacer 188. In some examples, opening 170 of bonepreparation guide 150 is size and/or shaped indexed to joint spacer 188such that there is substantially no, or no, relative movement betweenthe guide and spacer (once bone preparation guide 150 is placed overjoint spacer 188). This arrangement can ensure that bone preparationguide 150 is positioned precisely at the location where guided by jointspacer 188.

In practice, once bone preparation guide 150 is placed over joint spacer188, the guide slots of the bone preparation guide may not be perfectlyaligned with the ends of the bones (e.g., first metatarsal 210 andmedial cuneiform 220) to be cut through the guide slots. Accordingly, inother configurations, opening 170 of bone preparation guide 150 may notbe sized and/or shaped and/or indexed to joint spacer 188. In otherwords, opening 170 of bone preparation guide 150 may have a differentcross-sectional size and/or shape than the cross-sectional size and/orshape of joint spacer 188. In these configurations, bone preparationguide 150 may actuate or rotate about an axis extending through thelength of joint spacer 188. As a result, after the clinician places bonepreparation guide 150 over joint spacer 188, the clinician may rotatebone preparation guide 150 around joint spacer 188 until the guide slotsof the bone preparation guide are better aligned with the ends of thebones to be cut (e.g., first metatarsal 210 and medial cuneiform 220).Depending on the configuration of opening 170 of bone preparation guide150 and the configuration of joint spacer 188, the guide may rotatefreely (e.g., 360 degrees) around the joint seeker or within a boundedangular range (e.g., from plus 20 degrees to minus 20 degrees from anormal position).

FIG. 35 illustrates one example configuration of a joint spacer 188 thatcan allow bone preparation guide 150 to rotate around the seeker. Asshown in the illustrated example, joint spacer 188 has a proximalportion 370 having a cylindrical cross-section and a distal portion 372having a rectangular cross-section. A leading edge of the distal portion372 is insertable into the joint between the first metatarsal 210 andthe medial cuneiform 220. Once bone preparation guide 150 is insertedover joint spacer 188, body 154 of the guide (FIG. 5) may be positionedabout the proximal portion 370. This can allow the guide to be rotatedaround the proximal portion.

In other configurations, opening 170 of bone preparation guide 150 maybe size and/or shape indexed to the cross-sectional size and/or shape ofjoint spacer 188 but still provide relative rotation between the twocomponents. For example, opening 170 may have a circular cross-sectionsized and shaped to receive proximal portion 370 of joint spacer 188from FIG. 35. Because both opening 170 of bone preparation guide 150 andproximal portion 370 of joint spacer 188 have circular cross-sections insuch an embodiment, the two components may rotate relative to eachother. FIG. 36A is a perspective view of an example configuration ofbone preparation guide 150 having an opening 170 with circularcross-sectional shape. FIG. 36B is a perspective view of the examplebone preparation guide of FIG. 36A shown with joint spacer 188 from FIG.35 inserted into the guide.

In embodiments where bone preparation guide 150 can rotate relative tojoint spacer 188, the bone positioning guide and/or joint spacer mayinclude a locking mechanism that is engageable to lock the rotationalangle of the bone preparation guide relative to the joint spacer. Forexample, bone preparation guide 150 may include a set screw with thumbwheel that can be rotated, causing a distal end of the set screw to bearagainst or retract away from joint spacer 188. In use, a clinician canrotate bone preparation guide 150 around joint spacer 188 until theguide slots of the bone preparation guide are best aligned with the endsof the bones to be cut (e.g., first metatarsal 210 and medial cuneiform220). The clinician can then engage the locking mechanism to preventfurther rotation of bone preparation guide 150 relative to joint spacer188 before performing further steps of the procedure.

Embodiments of the invention also include a disposable, sterile kit thatincludes an embodiment of a bone positioning guide and/or preparationguide described herein. Other components that may be included within thesterile kit include bone fixation devices.

Thus, embodiments of the invention are disclosed. Although the presentinvention has been described with reference to certain disclosedembodiments, the disclosed embodiments are presented for purposes ofillustration, and not limitation, and other embodiments of the inventionare possible. One skilled in the art will appreciate that variouschanges, adaptations, and modifications may be made without departingfrom the spirit of the invention.

The invention claimed is:
 1. A method of performing a multi-planarrealignment of a metatarsal, the method comprising: making an incisionon a foot to provide access to a tarsal-metatarsal joint; performing asoft tissue release to mobilize the tarsal-metatarsal joint; moving afirst metatarsal relative to a medial cuneiform in at least two planes,including a frontal plane and a transverse plane, to establish a movedposition of the first metatarsal; after moving the first metatarsalrelative to the medial cuneiform, preparing an end of the firstmetatarsal; after moving the first metatarsal relative to the medialcuneiform, preparing an end of the medial cuneiform; fixing the movedposition of the first metatarsal relative to the medial cuneiform byinserting a fixation device across the tarsal-metatarsal joint.
 2. Themethod of claim 1, wherein moving the first metatarsal relative to themedial cuneiform in at least two planes comprises moving the firstmetatarsal relative to the medial cuneiform in three planes.
 3. Themethod of claim 1, further comprising, after preparing the end of thefirst metatarsal and after preparing the end of the medial cuneiform,compressing the first metatarsal together with the medial cuneiform. 4.The method of claim 1, further comprising, after preparing the end ofthe first metatarsal and after preparing the end of the medial cuneiformbut prior to fixing the moved position of the first metatarsal relativeto the medial cuneiform, provisionally fixing the moved position byinserting a fixation wire in the first metatarsal and into a secondmetatarsal to hold the moved position.
 5. The method of claim 1, whereinthe fixation device comprises an intramedullary implant.
 6. The methodof claim 5, wherein inserting the fixation device across thetarsal-metatarsal joint comprises inserting the intramedullary implantthrough the end of the first metatarsal, through the end of the medialcuneiform, and across the tarsal-metatarsal joint.
 7. The method ofclaim 1, wherein the fixation device comprises a plate, and insertingthe fixation device across the tarsal-metatarsal joint comprisesscrewing the plate to the first metatarsal and screwing the plate to themedial cuneiform.
 8. The method of claim 1, wherein: preparing the endof the first metatarsal comprises cutting the end of the firstmetatarsal; and preparing the end of the medial cuneiform comprisescutting the end of the medial cuneiform.
 9. The method of claim 1,further comprising attaching a bone positioning guide to the firstmetatarsal and the medial cuneiform.
 10. The method of claim 9, whereinthe bone positioning guide comprises a generally C-shaped body.
 11. Themethod of claim 9, wherein moving the first metatarsal relative to themedial cuneiform comprises moving the first metatarsal relative to themedial cuneiform using the bone positioning guide.
 12. The method ofclaim 1, wherein moving the first metatarsal relative to the medialcuneiform comprises moving the first metatarsal in the transverse planeby at least reducing an angle between the first metatarsal and a secondmetatarsal to 10 degrees or less.
 13. The method of claim 12, whereinmoving the first metatarsal in the transverse plane comprises reducingthe angle between the first metatarsal and the second metatarsal tobetween about 1 degree and 5 degrees.
 14. The method of claim 1, whereinmoving the first metatarsal relative to the medial cuneiform in thefrontal plane further comprises rotating a tibial sesamoid bone and afibular sesamoid bone within the frontal plane.
 15. The method of claim1, wherein moving the first metatarsal relative to the medial cuneiformin the frontal plane comprises rotating the first metatarsal to ametatarsal rotation ranging from about 0 degrees to 2 degrees.
 16. Themethod of claim 1, wherein preparing the end of the first metatarsalcomprises preparing the end of the first metatarsal after preparing theend of the medial cuneiform.
 17. The method of claim 1, wherein makingthe incision comprises making the incision on a dorsal side of the foot.18. A method of performing a multi-planar realignment of a metatarsal,the method comprising: making an incision on a foot to provide access toa tarsal-metatarsal joint; performing a soft tissue release to mobilizethe tarsal-metatarsal joint; moving a first metatarsal relative to amedial cuneiform in multiple planes, including a frontal plane, atransverse plane, and a sagittal plane, to establish a moved position ofthe first metatarsal; after moving the first metatarsal relative to themedial cuneiform, preparing an end of the first metatarsal; after movingthe first metatarsal relative to the medial cuneiform, preparing an endof the medial cuneiform; after preparing the end of the first metatarsaland after preparing the end of the medial cuneiform, provisionallyfixing the moved position of the first metatarsal relative to the medialcuneiform by inserting a fixation wire in the first metatarsal and intoa second metatarsal to hold the moved position; and after provisionallyfixing the moved position, fixing the moved position of the firstmetatarsal relative to the medial cuneiform by inserting a fixationdevice across the tarsal-metatarsal joint.
 19. The method of claim 18,further comprising, after preparing the end of the first metatarsal andafter preparing the end of the medial cuneiform, compressing the firstmetatarsal together with the medial cuneiform.
 20. The method of claim18, wherein: the fixation device comprises an intramedullary implant,and inserting the fixation device across the tarsal-metatarsal jointcomprises inserting the intramedullary implant through the end of thefirst metatarsal, through the end of the medial cuneiform, and acrossthe tarsal-metatarsal joint.
 21. The method of claim 18, wherein thefixation device comprises a plate, and inserting the fixation deviceacross the tarsal-metatarsal joint comprises screwing the plate to thefirst metatarsal and screwing the plate to the medial cuneiform.
 22. Themethod of claim 18, wherein: preparing the end of the first metatarsalcomprises cutting the end of the first metatarsal; and preparing the endof the medial cuneiform comprises cutting the end of the medialcuneiform.
 23. The method of claim 18, further comprising attaching abone positioning guide having a generally C-shaped body to the firstmetatarsal and the medial cuneiform, wherein moving the first metatarsalrelative to the medial cuneiform comprises moving the first metatarsalrelative to the medial cuneiform using the bone positioning guide. 24.The method of claim 18, wherein: moving the first metatarsal relative tothe medial cuneiform comprises moving the first metatarsal in thetransverse plane by at least reducing an angle between the firstmetatarsal and a second metatarsal to between about 1 degree and 5degrees, and moving the first metatarsal relative to the medialcuneiform in the frontal plane comprises rotating the first metatarsalto a metatarsal rotation ranging from about 0 degrees to 2 degrees. 25.The method of claim 18, wherein making the incision comprises making theincision on a dorsal side of the foot.